Steven D. Pearson, MD, MSc, FRCP
President, Institute for Clinical and Economic Review
One State Street
Suite 1050
Boston, MA 02109 USA
BY ELECTRONIC DELIVERY
RE: Institute for Clinical and Economic Review (ICER) Value Framework
Dear Dr. Pearson:
On behalf of the Biotechnology Industry Organization (BIO), I would like to submit the following feedback with respect to ICER’s Value Framework, presented on September 15, 2015. BIO advocates on behalf of biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

RE: Centers for Medicare and Medicaid Services Healthcare Common Procedure Coding System Public Meeting, May 7, 2015
Dear Ms. Carver:
The Biotechnology Industry Organization (BIO) is pleased to provide comments in response to the May 7 Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Public Meeting Agenda for Drugs, Biologicals and Radiopharmaceuticals (“Public Meeting Agenda”).

The U.S. Biotech Crops Alliance greatly appreciates your efforts to elevate the U.S.- China dialogue on agricultural innovation. Your engagement with President Xi Jinping at the 2014 APEC Summit established a strong foundation on which to build a robust, mutually beneficial, long-term dialogue on cooperation as it relates to agricultural innovation, including global food security, climate unpredictability and rural economic growth. In this regard, we ask that practical, trade facilitating measures to ensure increased Chinese access to the products of U.S. agriculture be a priority for your upcoming meeting with President Xi.

The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed rule entitled Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 20161 (the “Proposed Rule”).

Now more than ever, American agriculture needs your continued engagement with China’s President Xi Jinping on agricultural innovation and trade. The undersigned organizations embrace innovation to continue reliably supplying our valued customers in China and in other markets around the world. Sustainably meeting the challenges of global food security is important not only for China, but for all countries, and requires access to innovation and to markets. For these reasons, we ask you to make securing positive action on pending biotechnology issues a priority when you meet with President Xi in Washington, D.C. later this month.

The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products.”

The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit the following comments to the Department of Health and Human Services (HHS) in response to the proposed rule issued by the Health Resources and Services Administration (HRSA) on June 17, 2015, entitled 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation [RIN-0906-AA89] (the “Proposed Rule”).